GIRAFFE OMNIBED

K101788 · Ohmeda Medical · FMZ · Jul 21, 2010 · General Hospital

Device Facts

• Record ID: K101788
• Device Name: GIRAFFE OMNIBED
• Applicant: Ohmeda Medical
• Product Code: FMZ · General Hospital
• Decision Date: Jul 21, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5400
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user's demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Incubators provide an enclosed, temperature-controlled environment and warmers provide infrared heat in an open environment. They may also be used for short periods of time to facilitate the neonate's transition from the uterus to the external environment. This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).

Device Story

Giraffe OmniBed is a combination neonatal incubator and radiant warmer. The subject modification adds the 'Giraffe Shuttle,' a mobile power source accessory. The Shuttle attaches to the bed base to provide electrical power during intra-hospital transport (e.g., between NICU, Radiology, OR). It features a mechanical locking mechanism (pedal-operated) and an internal power source consisting of two 12V 42Ah lead-acid batteries. The Shuttle includes sensors for interference detection and attachment status, with an LED display for battery health and runtime. The device is operated by hospital staff. By providing continuous power, the Shuttle enables uninterrupted thermal regulation and monitoring during patient movement, reducing the need for transfer to separate transport incubators and minimizing handling-related clinical risks. It is not intended for use outside the hospital building.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including risk analysis, requirements/design reviews, module and system-level verification, performance/safety testing, and usability validation.

Technological Characteristics

Combination incubator/radiant warmer with mobile power accessory (Giraffe Shuttle). Shuttle utilizes two 12V 42Ah sealed lead-acid batteries in series (24V nominal). Features mechanical locking pedal, LED display for battery status, and sensors for interference/attachment detection. Connectivity is limited to power delivery to the bed and auxiliary equipment. Biocompatibility and safety testing performed per voluntary standards.

Indications for Use

Indicated for neonates unable to thermo-regulate based on their own physiology. Provides controlled heat via incubator or radiant warmer modes and optional servo-controlled oxygen delivery (21-65%).

Regulatory Classification

Identification

A neonatal incubator is a device consisting of a rigid boxlike enclosure in which an infant may be kept in a controlled environment for medical care. The device may include an AC-powered heater, a fan to circulate the warmed air, a container for water to add humidity, a control valve through which oxygen may be added, and access ports for nursing care.

Predicate Devices

• Giraffe OmniBed (K101788)

Submission Summary (Full Text)

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K10/788
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JUL 2-1 2010

Image /page/0/Picture/2 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circle. The circle has decorative swirls around the letters, and small dots are placed around the perimeter of the circle.

GE Healthcare Special 510(k) Premarket Notification Submission 510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

| Date: | June 16 2010 |
|-----------------------------------|-----------------------------------------------------------------------------------------------|
| Submitter: | GE Healthcare, Ohmeda Medical<br>8880 Gorman Rd.<br>Laurel, MD 20723 |
| Primary Contact Person: | Agata Smieja<br>8880 Gorman Rd.<br>Laurel, MD 20723<br>Tel: [phone]<br>Fax: [phone] |
| Secondary Contact Person: | Andrew Ahn<br>8880 Gorman Rd.<br>Laurel, MD 20723<br>Tel: [phone]<br>Fax: [phone] |
| Device:<br>Trade Name: | Giraffe OmniBed |
| Common/Usual Name: | OmniBed |
| Classification Names: | Incubator, Neonatal: FMZ (880.5400) |
| Product Code: | Warmer, Infant Radiant: FMT (880.5130) |
| Predicate Device(s): | Giraffe OmniBed |
| Device and Change<br>Description: | Legally Marketed Device<br>Giraffe OmniBed is a combination device |

hat can function as an incubator (in the closed mode) or as an infant radiant warmer (in the open mode), based on the user's selection. The device cannot function in both modes at the same time.

Giraffe OmniBed can be used with the Giraffe Uninterruptible Power Supply (UPS) accessory. The UPS is an accessory that mounts to the Giraffe OmniBed as well as the Giraffe Incubator and the Giraffe and Panda Warmers. Giraffe UPS provides uninterruptible power to the bed for quick trips. It also allows thermally supported, cordless mobility during periods of power uncertainty. Whether moving between bed places, or between care areas, the UPS for Giraffe and Panda offers uninterrupted power to the bed and display for continuous monitoring of the baby's situation, and bed controls.

When used with the UPS, the Giraffe OmniBed are is not intended for use as transport incubator or to be taken outside of the hospital

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K101788
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GE Healthcare

Special 510(k) Premarket Notification Submission building.

Description of Device Modification

The proposed modification of the Giraffe OmniBed is the addition of the Giraffe Shuttle accessory.

The Giraffe OmniBed can be used with the Giraffe Shuttle, a mobile power source that allows for transport of the patient between care areas within the hospital building and provides power to the OmniBed. These areas include, but are not limited to Labor and Delivery, NICU, Radiology, and Operating Room.

This eliminates the need to transfer the infant to and from a transport incubator for transport within the hospital building, reducing the potential for clinical problems associated with patient touch, handling and movement. This reduces the potential for clinical problems associated with intra-hospital transport that result from interrupted patient thermal regulation. .

Similarly to the UPS accessory, the Shuttle facilitates the mobility of the Giraffe OmniBed within the hospital building. Giraffe OmniBed when used with the UPS or with the Shuttle is not a transport incubator and is not intended to be used outside of the hospital building.

The Shuttle has two primary active functions: Locking to a bed and providing transportable power to the bed and accessories.

Attaching the Shuttle to a bed is accomplished by guiding the Shuttle between the legs of the bed and stepping on the Lock pedal. This effectively locks the Shuttle and bed together as one unit.

To detach the Shuttle from the bed, the locking arms are rotated back to their unlocked position by stepping on the Unlock pedal. Once unlocked, the Shuttle can be moved away from the bed.

The internal power source of the Shuttle consists of two 12 volt 42 amp hour lead acid batteries. The batteries are high capacity, sealed, no-maintenance batteries and are connected in series to provide a nominal 24 volts supply to the power generation module.

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## GE Healthcare

## Legally Marketed Device Intended Use:

Special 510(k) Premarket Notification Submission The intended use of the legally marketed device and the proposed modified device is identical. The intended use is as follows:

The OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user's demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology.

Incubators provide an enclosed, temperature-controlled environment and warmers provide infrared heat in an open environment. They may also be used for short periods of time to facilitate the neonate's transition from the uterus to the external environment.

This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).

Device Modification Technology:

The Giraffe Shuttle is a transportable power source that is an accessory to the Giraffe OmniBed. The Shuttle connects to the bed and provides electrical power to the bed and other auxiliary equipment, required for patient care during transport.

The Shuttle is configured to attach to the Giraffe OmniBed and provide electrical power to the bed and selected accessories. The Shuttle makes it possible to deliver continuous baby care during transport from one hospital area to another (e.g. from L&D to NICU).

The Shuttle is designed to accept all Shuttle-specific accessories from GE Healthcare, including: the cord wrap bracket and gas cylinder holder.

The Shuttle has two primary active functions: Locking to a bed and providing transportable power to the bed and accessories.

The Shuttle contains two sensor systems:

- One system detects an interference condition.
- The other system determines the attaching status of the device.

The Shuttle features an LED Display Board, which contains the battery runtime indicator and the battery health indicator.

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Image /page/3/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circular border. There are four decorative elements resembling small swirls or flourishes positioned symmetrically around the circle, enhancing the logo's visual appeal. The logo is presented in black against a white background, providing a clear contrast.

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GE Healthcare Special 510(k) Premarket Notification Submission

Summary of Non-Clinical Tests: Determination of Substantial Equivalence:

> The Giraffe OmniBed and its applications with the Giraffe Shuttle, complies with voluntary standards as detailed in Section 9, 11 and 17 The following quality assurance of this premarket submission. measures were applied to the development of the system:

- . Risk Analysis
- Requirements Reviews .
- . Design Reviews
- Testing on unit level (Module verification) ●
- � Integration testing (System verification)
- . Performance testing (Verification)
- . Safety testing (Verification)
- Usability testing (Validation) .
- Biocompatibility testing

## Clinical Tests:

The subject of this premarket submission, Giraffe OmniBed used with Shuttle, did not require clinical studies to support substantial equivalence.

Conclusion: GE Healthcare considers the modified Giraffe OmniBed, used with the Giraffe Shuttle accessory to be as safe, as effective, and performance is substantially equivalent to the legally marketed Giraffe OmniBed.

25

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

## JUL 2-1 2010

Mr. Agata Smieja Regulatory Affairs Director OHMEDA Medical 8880 Gorman Road Laurel, Maryland 20723

Re: K101788

Trade/Device Name: Giraffe OmniBed Regulation Number: 21 CFR 880.5400 Regulation Name: Neonatal Incubator Regulatory Class: II Product Code: FMZ Dated: June 16, 2010 Received: June 25, 2010

Dear Mr. Smieja:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2- Mr. Smieja

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Wh for

Anthony D. watson, B.S., M.S.m M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices

Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters are stylized and connected, creating a recognizable emblem for the company.

GE Healthcare Special 510(k) Premarket Notification Submission

510(k) Number (if known):

INSERT 510(k). NUMBER IF KNOWN

Device Name: Giraffe OmniBed

Indications for Use:

The OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user's demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology.

Incubators provide an enclosed, temperature-controlled environment and warmers provide infrared heat in an open environment. They may also be used for short periods of time to facilitate the neonate's transition from the uterus to the external environment.

This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).

Prescription Use__x___________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

e of Device Evaluation (ODE)

7/20/10

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Numb